Empirically-Based Couple Interventions on the Web: Serving the Underserved

Relationship, Marital Clinical Trial

Official title:

Empirically-Based Couple Interventions on the Web: Serving the Underserved

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292692
• Other study ID #: 20120378
• Secondary ID: R01HD059802
• Status: Completed
• Phase: N/A
• First received: September 20, 2017
• Last updated: February 8, 2018
• Start date: August 13, 2013
• Est. completion date: October 18, 2014

Study information

• Verified date: February 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although several empirically-supported interventions to prevent and treat relationship distress have been developed, the majority of couples - especially high-risk couples - do not seek these face-to-face interventions. However, our pilot data indicate that large numbers of couples will seek self-administered assistance for their relationship. Additionally, unlike many in-person interventions, couples seeking self-help resources tend to have higher levels of relationship distress. Thus, to improve the reach of couple interventions, this project will translate a leading empirically-supported intervention targeting early signs of relationship distress into a Web-based format. This intervention will consist of individualized feedback and professionally-filmed video clips tailored to a couple's specific needs. By intervening effectively with a large number of couples, the resulting Web-based intervention has the potential to have a population-level impact on relationship distress, divorce, and resulting child difficulties.

In the proposed project, building off our previous pilot studies, effective translation of this in-person intervention into a Web-based format will be ensured by conducting two additional intensive pilot studies. Once final changes have been made to the website and Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or an online intervention. All couples will be assessed for the initial two months; intervention couples will be assessed for one year. This project will: 1) demonstrate that couples randomly assigned to the online intervention will report higher levels of individual, child, and relationship functioning than those in the wait-list control group; 2) document the mechanisms of both active conditions; and 3) show that initial gains in those assigned to the intervention are largely maintained through one-year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 18, 2014
• Est. primary completion date: October 18, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

• Currently in a heterosexual relationship

• Currently married, engaged, or cohabiting for at least 6 months

• At least one partner scoring in distressed range of relationship satisfaction (or both partners > 0.5 SD of population mean of distress).

• Living in the United States

• Both partners ages 21-64 (inclusive)

Exclusion Criteria:

• Severe Intimate Partner Violence in last 3 months

• Moderate to severe suicidal ideation in last 3 months

• Concrete plans to divorce

• Ongoing affair

• Ongoing couple therapy (or refusal to seek couple therapy for 3 months)

Related Conditions & MeSH terms

• Marital Conflict
• Relationship, Marital

Intervention

Behavioral:
• OurRelationship
Online intervention with coach support

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, University of Washington

References & Publications (2)

Doss BD, Cicila LN, Georgia EJ, Roddy MK, Nowlan KM, Benson LA, Christensen A. A randomized controlled trial of the web-based OurRelationship program: Effects on relationship and individual functioning. J Consult Clin Psychol. 2016 Apr;84(4):285-96. doi: — View Citation

Roddy MK, Georgia EJ, Doss BD. Couples with Intimate Partner Violence Seeking Relationship Help: Associations and Implications for Self-Help and Online Interventions. Fam Process. 2017 Apr 20. doi: 10.1111/famp.12291. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship Satisfaction	Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk & Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.	Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
Secondary	Relationship Confidence	Relationship confidence as measured by 2 items from the Confidence Scale ("I believe we can handle whatever conflicts will arise in the future" and "I feel good about our prospects to make this relationship work"). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388).	Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
Secondary	Depressive Symptoms	Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, & Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.	Pre (0 weeks) and Post (approximately 6 weeks)
Secondary	Anxiety Symptoms	Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.	Pre (0 weeks) and Post (approximately 6 weeks)